Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Sterilisation von Medizinprodukten - Validierung und Routineüberwachung für die Sterilisation mit Strahlen

Stérilisation de dispositifs médicaux - Validation et contrôle de routine de la stérilisation par irradiation

Sterilizacija medicinskih pripomočkov - Validacija in rutinska kontrola sterilizacije z obsevanjem

General Information

Status
Withdrawn
Publication Date
21-Nov-2000
Withdrawal Date
14-Apr-2006
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
CEN/TC 204 - Sterilization of medical devices
Drafting Committee
CEN/TC 204 - Sterilization of medical devices
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
15-Apr-2006
Completion Date
15-Apr-2006
Directive
93/42/EEC - Medical devices
98/79/EC - In vitro diagnostic medical devices
Mandate
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN 552:2000/A2:2001 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Relations

Replaced By
EN ISO 11137-2:2006 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
Effective Date
22-Dec-2008
Replaced By
EN ISO 11137-3:2006 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)
Effective Date
22-Dec-2008
Replaced By
EN ISO 11137-1:2006 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
Effective Date
22-Dec-2008
Referred By
EN ISO 21049:2004 - Pumps - Shaft sealing systems for centrifugal and rotary pumps (ISO 21049:2004)
Effective Date
28-Jan-2026
Referred By
EN ISO 13710:2004 - Petroleum, petrochemical and natural gas industries - Reciprocating positive displacement pumps (ISO 13710:2004)
Effective Date
28-Jan-2026
Referred By
EN ISO 10438-1:2007 - Petroleum, petrochemical and natural gas industries - Lubrication, shaft-sealing and control-oil systems and auxiliaries - Part 1: General requirements (ISO 10438-1:2007)
Effective Date
28-Jan-2026
Referred By
EN ISO 13705:2006 - Petroleum, petrochemical and natural gas industries - Fired heaters for general refinery service (ISO 13705:2006)
Effective Date
28-Jan-2026
Amends
EN 552:1994 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation
Effective Date
22-Dec-2008

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Frequently Asked Questions

EN 552:1994/A2:2000 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Sterilization of medical devices - Validation and routine control of sterilization by irradiation". This standard covers: Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

EN 552:1994/A2:2000 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 552:1994/A2:2000 has the following relationships with other standards: It is inter standard links to EN ISO 11137-2:2006, EN ISO 11137-3:2006, EN ISO 11137-1:2006, EN ISO 21049:2004, EN ISO 13710:2004, EN ISO 10438-1:2007, EN ISO 13705:2006, EN 552:1994. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 552:1994/A2:2000 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC, 98/79/EC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

EN 552:1994/A2:2000 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-november-2001
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY9DOLGDFLMDLQUXWLQVNDNRQWURODVWHULOL]DFLMH
]REVHYDQMHP
Sterilization of medical devices - Validation and routine control of sterilization by
irradiation
Sterilisation von Medizinprodukten - Validierung und Routineüberwachung für die
Sterilisation mit Strahlen
Stérilisation de dispositifs médicaux - Validation et contrôle de routine de la stérilisation
par irradiation
Ta slovenski standard je istoveten z: EN 552:1994/A2:2000
ICS:
11.080.01 Sterilizacija in dezinfekcija na
...

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